Looking for a Regulatory Affairs Officer job in Ankleshwar? Icpa Health Products Ltd is hiring Regulatory Affairs Officer (Plant RA) professionals with formulation experience and expertise in global markets including EU, UK, Australia, and Ukraine.
This Pharmaceutical Regulatory Affairs job in Gujarat is ideal for B.Pharm or M.Pharm candidates with 1–4 years of experience in dossier preparation, CTD/ACTD formats, and ICH guidelines compliance. Immediate joiners are preferred.
📌 Job Overview
- Position: Regulatory Affairs Officer (Plant RA)
- Location: Ankleshwar, Gujarat
- Experience: 1–4 Years
- Salary: ₹2.5 – ₹4.5 LPA (Approx.)
- Industry: Pharmaceutical & Life Sciences
- Employment Type: Full-Time, Permanent
- Openings: 3
🔎 Key Responsibilities
The Regulatory Affairs Officer will be responsible for:
- Preparation and compilation of regulatory dossiers in CTD & ACTD format
- Handling regulatory documentation for EU, UK, Australia & Ukraine markets
- Ensuring compliance with ICH guidelines and international regulatory requirements
- Regulatory submissions and lifecycle management
- Managing plant-level regulatory documentation
- Coordinating with QA, QC, and production teams for compliance
- Maintaining proper document management systems
- Ensuring audit readiness and regulatory inspection support
This role requires strong expertise in Regulatory Affairs compliance, dossier compilation, and global submission processes.
🎓 Qualifications & Eligibility
- UG: B.Pharm (Mandatory)
- PG: M.Pharm (Preferred)
- Experience: 1–4 years in Regulatory Affairs (Plant RA)
- Mandatory: Formulation experience
- Strong knowledge of:
- CTD & ACTD Dossier Preparation
- EU & UK Regulatory Requirements
- ICH Guidelines
- Regulatory Documentation & Submissions
- Excellent communication and documentation skills
💼 Required Skills
- Regulatory Guidelines expertise
- Dossier Preparation & Compilation
- Regulatory Submissions
- Regulatory Compliance Management
- CTD Documentation
- Plant Regulatory Affairs coordination
🎁 Benefits
- Opportunity to work in a reputed oral healthcare pharmaceutical company
- Exposure to international markets (EU, UK, Australia, Ukraine)
- Competitive salary package (₹2.5–4.5 LPA)
- Career growth in global Regulatory Affairs
🏢 About Icpa Health Products Ltd
Icpa Health Products Ltd, established in 1972, is a leading player in the Indian oral healthcare segment. Headquartered in Ankleshwar with pan-India operations, the company offers a comprehensive portfolio catering to dental professionals across the country.
📩 How to Apply
